Low Back PainNCT05907356
Effect of Sciatic Nerve Slider Technique in Different Positions in Low Back Pain Patients
A study testing sciatic nerve slider technique in slump lying position, sciatic nerve slider technique in supine position and Conventional physiotherapy in people with Low Back Pain and Sciatica, run by European University of Lefke at 1 site in Palestinian Territories.
Trial summary
Neural mobilization is a technique that plays an important role in repairing the neural tissue's ability to respond to stress or tension by triggering the reconstruction of normal physiological functioning, pain reduction, and functional improvement. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Low Back Pain, Sciatica
- What is being tested?
- sciatic nerve slider technique in slump lying position, sciatic nerve slider technique in supine position and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Apr 2023to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range between 40 - 65 years,
- Both genders,
- Diagnosed by magnetic resonance imaging to confirm disc lesion,
- LBP with radicular pain for more than 12 weeks up to 1 year with no acute episodes in the last 4 weeks, and a numeric pain rating score (NPRS) greater than 4/10.
- Positive SLR test with reproduction of neurological symptoms.
Who cannot join
- Sciatica due to other pathologies (e.g. lumbar canal stenosis or piriformis syndrome),
- Having any physiotherapy before 6 months.
- History of spinal surgery
- Vertebral fracture or trauma,
- Negative SLR test,
- pregnant.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Princess Alia Governmental Hospital
Hebron, West Bank
About this study
Official title: Comparison of Sciatic Nerve Slider Technique in Different Positions in Patients With Low Back Pain Associated With Sciatica: Randomized Control Trial
Neural mobilization is a technique that plays an important role in repairing the neural tissue's ability to respond to stress or tension by triggering the reconstruction of normal physiological functioning, pain reduction, and functional improvement. The study aims to examine the effect of the sciatic nerve slider technique in different positions and which of the most common positions is more effective in the application of neural mobilization in low back pain with sciatica.
Read the detailed description
Low back pain (LBP) is one of the most common musculoskeletal disorders, accounting for a significant portion of disability. It's a severe healthcare burden that has large societal costs, according to estimates, LBP can affect anywhere between 22% and 65% of people within a year. Additionally, back pain-related absences from work result in prolonged periods of sick leave, which has an adverse effect on workplace productivity.
Sciatica is the name given to a collection of symptoms caused by compression and irritation of the sciatic nerve, including pain, numbness, muscular weakness, and difficulty moving or controlling the legs. The lower back, buttocks, and multiple dermatomes of the leg and foot are typically where symptoms appear. Sciatica can be caused by a disc bulge or herniation, lumbar canal stenosis, spondylolisthesis, trauma, piriformis syndrome, or spinal tumors. It affects women more than men and people who lead sedentary lifestyles more than active ones. It might arise quickly or gradually with physical activity, and it is usually unilateral.
The slider and tensioner are two distinct types of neural mobilization procedures. There are clinical improvements and positive therapeutic benefits after treatment with different neural mobilization techniques, but the slider technique is safer, involves less stretching and strain of the nerves, and has a more significant effect than the tensioner technique.
- Conditions
- Low Back Pain, Sciatica
- Being tested
- sciatic nerve slider technique in slump lying position, sciatic nerve slider technique in supine position, Conventional physiotherapy
- Keywords
- low back pain, Neuromobilization, Sciatic nerve Slider technique, Positions
- Medical subject headings
- Low Back Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sciatic nerve slider technique in slump lying positionOther
The patient will be sitting at the edge of the couch with the posterior aspect of the knee at the edge, the thighs parallel to each other, and flexion at the thoracic and lumbar spines (slouch position). The therapist will be standing at the bedside of the patient with a proximal arm over the patient's shoulder and one hand guiding the neck movements of the patient and the other hand guiding the knee movements, passively performing cervical neck flexion with knee flexion (stretching the nerve proximally and relaxing at the distal end) and then moving into cervical extension with knee extension. Provide five sets in every session: the first: 10 repetitions, the second: 15 repetitions, the third: 20 repetitions, the fourth: 25 repetitions; and the fifth: 30 repetitions. The end position is held for 5 seconds, and the rest between sets is 1-2 minutes
sciatic nerve slider technique in supine positionOther
.The patient will be in a supine position. The therapist will hold the patient's limb passively and then move the hip into flexion with the ankle in plantar flexion and the knee in extension, stretching the nerve at the hip and relaxing at the ankle, Then reversing the movement with the hip into extension, maintaining the knee in extension and the ankle in dorsiflexion, relaxing the nerve at the hip and stretching at the ankle. Provide five sets in every session; the first: 10 repetitions, the second: 15 repetitions, the third: 20 repetitions, the fourth: 25 repetitions, and the fifth: 30 repetitions. The end position is held for 5 seconds, and the rest between sets is 1-2 minutes.
Conventional physiotherapyOther
The patient will receive conventional physiotherapy, which includes: a moist hot pack, TENS, and back strengthening exercises (as a home program).
| Study group | Role | What they receive |
|---|---|---|
| Study Group One | Experimental | sciatic nerve slider technique in a slump lying position in combination with Conventional physiotherapy Receives: Other: sciatic nerve slider technique in slump lying position; Other: Conventional physiotherapy |
| Study Group Two | Experimental | sciatic nerve slider technique in a supine position in combination with Conventional physiotherapy Receives: Other: sciatic nerve slider technique in supine position; Other: Conventional physiotherapy |
| Control Group | Experimental | Conventional physiotherapy alone Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
A numeric pain rating scale (NPRS) will be used to evaluate pain intensity. The scale has a length of 10 cm and a range of 0-10, Here, a score of zero (zero) denotes the absence of pain, a score of one to three (1-3) denotes mild pain, a score of three to five (moderate pain), and a score of six to ten (severe pain)
Measured: 4 weeks
Oswestry Disability Index (ODI)
The disability caused by low back pain will be measured via the Arabic version of the Oswestry Disability Index. The patient will fill out the questionnaire in about 5 minutes, and then the therapist will score it in about 1 minute. The patient marks the most relevant answer for each question as accurately as they can. The scoring system employs a numerical scale from 0 to 5, with the first possible answer being 0 and the last possible answer being 5. The maximum possible score for each section is 5. All the scores will be added together and divided by the total number of possible points to calculate the total score
Measured: 4 weeks
Modified Schober test
Lumbar flexion flexibility will be measured by the modified Schober test. The patient will be standing, and the examiner will mark the L5 spinous process by drawing a horizontal line across the patient's back. A second line is marked 10 cm above the first line. The patient is then instructed to flex forward as if attempting to touch his/her toes, and the examiner remeasures the distance between two lines with the patient fully flexed. The difference between the measurements in the erect and flexion positions indicates the outcome of the lumbar flexion.
Measured: 4 weeks
Hand-held dynamometry
The hand-held dynamometer has good to excellent reliability and validity for most measures of muscle strength, it portable device that is an appropriate and convenient method to assess lower limb muscle strength. to Assessment of isometric muscle strength and power will be performed with the participants in three positions (seated, supine, and prone); hip flexors, knee extensors, and knee flexors were assessed in a seated position; ankle plantar flexors, ankle dorsiflexors, hip abductors, and hip adductors in a supine position; hip extensors in a prone position
Measured: 4 weeks
Flexible ruler
The lumbar lordosis will be measured by a flexible ruler. It is commonly used to measure the degree of spinal curvature of the lumbar lordosis in the sagittal plane. It is a safe, easy-to-use, and inexpensive tool.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Apr 2023
- Primary completion20 Nov 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beliz Belgen Kaygisiz, PT, PhD, Principal investigator, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907356
- Sponsor's protocol ID
- BAYEK022.06
- Status last verified
- Aug 2024
- First submitted
- 28 May 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sciatic Nerve Slider Technique in Different Positions in Patients With Low Back Pain Associated With Sciatica: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05907356
- Acronym / sponsor ID
- BAYEK022.06
- Conditions
- Low Back Pain, Sciatica
- Keywords
- low back pain, Neuromobilization, Sciatic nerve Slider technique, Positions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neural mobilization is a technique that plays an important role in repairing the neural tissue's ability to respond to stress or tension by triggering the reconstruction of normal physiological functioning, pain reduction, and functional improvement. The study aims to examine the effect of the sciatic nerve slider technique in different positions and which of the most common positions is more effective in the application of neural mobilization in low back pain with sciatica.
Detailed description
Low back pain (LBP) is one of the most common musculoskeletal disorders, accounting for a significant portion of disability. It's a severe healthcare burden that has large societal costs, according to estimates, LBP can affect anywhere between 22% and 65% of people within a year. Additionally, back pain-related absences from work result in prolonged periods of sick leave, which has an adverse effect on workplace productivity.
Sciatica is the name given to a collection of symptoms caused by compression and irritation of the sciatic nerve, including pain, numbness, muscular weakness, and difficulty moving or controlling the legs. The lower back, buttocks, and multiple dermatomes of the leg and foot are typically where symptoms appear. Sciatica can be caused by a disc bulge or herniation, lumbar canal stenosis, spondylolisthesis, trauma, piriformis syndrome, or spinal tumors. It affects women more than men and people who lead sedentary lifestyles more than active ones. It might arise quickly or gradually with physical activity, and it is usually unilateral.
The slider and tensioner are two distinct types of neural mobilization procedures. There are clinical improvements and positive therapeutic benefits after treatment with different neural mobilization techniques, but the slider technique is safer, involves less stretching and strain of the nerves, and has a more significant effect than the tensioner technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group One | Experimental | Other: sciatic nerve slider technique in slump lying position, Other: Conventional physiotherapysciatic nerve slider technique in a slump lying position in combination with Conventional physiotherapy |
| Study Group Two | Experimental | Other: sciatic nerve slider technique in supine position, Other: Conventional physiotherapysciatic nerve slider technique in a supine position in combination with Conventional physiotherapy |
| Control Group | Experimental | Other: Conventional physiotherapyConventional physiotherapy alone |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range between 40 - 65 years,
- Both genders,
- Diagnosed by magnetic resonance imaging to confirm disc lesion,
- LBP with radicular pain for more than 12 weeks up to 1 year with no acute episodes in the last 4 weeks, and a numeric pain rating score (NPRS) greater than 4/10.
- Positive SLR test with reproduction of neurological symptoms.
Key exclusion criteria (6 listed)
- Sciatica due to other pathologies (e.g. lumbar canal stenosis or piriformis syndrome),
- Having any physiotherapy before 6 months.
- History of spinal surgery
- Vertebral fracture or trauma,
- Negative SLR test,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sciatic nerve slider technique in slump lying positionThe patient will be sitting at the edge of the couch with the posterior aspect of the knee at the edge, the thighs parallel to each other, and flexion at the thoracic and lumbar spines (slouch position). The therapist will be standing at the bedside of the patient with a proximal arm over the patient's shoulder and one hand guiding the neck movements of the patient and the other hand guiding the knee movements, passively performing cervical neck flexion with knee flexion (stretching the nerve proximally and relaxing at the distal end) and then moving into cervical extension with knee extension. Provide five sets in every session: the first: 10 repetitions, the second: 15 repetitions, the third: 20 repetitions, the fourth: 25 repetitions; and the fifth: 30 repetitions. The end position is held for 5 seconds, and the rest between sets is 1-2 minutes | Other | Study Group One |
| sciatic nerve slider technique in supine position.The patient will be in a supine position. The therapist will hold the patient's limb passively and then move the hip into flexion with the ankle in plantar flexion and the knee in extension, stretching the nerve at the hip and relaxing at the ankle, Then reversing the movement with the hip into extension, maintaining the knee in extension and the ankle in dorsiflexion, relaxing the nerve at the hip and stretching at the ankle. Provide five sets in every session; the first: 10 repetitions, the second: 15 repetitions, the third: 20 repetitions, the fourth: 25 repetitions, and the fifth: 30 repetitions. The end position is held for 5 seconds, and the rest between sets is 1-2 minutes. | Other | Study Group Two |
| Conventional physiotherapyThe patient will receive conventional physiotherapy, which includes: a moist hot pack, TENS, and back strengthening exercises (as a home program). | Other | Control Group, Study Group One, Study Group Two |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 4 weeks
A numeric pain rating scale (NPRS) will be used to evaluate pain intensity. The scale has a length of 10 cm and a range of 0-10, Here, a score of zero (zero) denotes the absence of pain, a score of one to three (1-3) denotes mild pain, a score of three to five (moderate pain), and a score of six to ten (severe pain)
Oswestry Disability Index (ODI)
Time frame: 4 weeks
The disability caused by low back pain will be measured via the Arabic version of the Oswestry Disability Index. The patient will fill out the questionnaire in about 5 minutes, and then the therapist will score it in about 1 minute. The patient marks the most relevant answer for each question as accurately as they can. The scoring system employs a numerical scale from 0 to 5, with the first possible answer being 0 and the last possible answer being 5. The maximum possible score for each section is 5. All the scores will be added together and divided by the total number of possible points to calculate the total score
Modified Schober test
Time frame: 4 weeks
Lumbar flexion flexibility will be measured by the modified Schober test. The patient will be standing, and the examiner will mark the L5 spinous process by drawing a horizontal line across the patient's back. A second line is marked 10 cm above the first line. The patient is then instructed to flex forward as if attempting to touch his/her toes, and the examiner remeasures the distance between two lines with the patient fully flexed. The difference between the measurements in the erect and flexion positions indicates the outcome of the lumbar flexion.
Hand-held dynamometry
Time frame: 4 weeks
The hand-held dynamometer has good to excellent reliability and validity for most measures of muscle strength, it portable device that is an appropriate and convenient method to assess lower limb muscle strength. to Assessment of isometric muscle strength and power will be performed with the participants in three positions (seated, supine, and prone); hip flexors, knee extensors, and knee flexors were assessed in a seated position; ankle plantar flexors, ankle dorsiflexors, hip abductors, and hip adductors in a supine position; hip extensors in a prone position
Flexible ruler
Time frame: 4 weeks
The lumbar lordosis will be measured by a flexible ruler. It is commonly used to measure the degree of spinal curvature of the lumbar lordosis in the sagittal plane. It is a safe, easy-to-use, and inexpensive tool.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beliz Belgen Kaygisiz, PT, PhD principal investigator
European University of Lefke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sciatic nerve slider technique in slump lying position, sciatic nerve slider technique in supine position and Conventional physiotherapy in people with Low Back Pain and Sciatica, run by European University of Lefke at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.